MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR 16X22MM IMPLANT HEAD; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Detachment Of Device Component (1104); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.Initial reporter - the article was written by roger e.Wiltfong, raymond k.Wurapa, and james c.Cassandra.Device location unknown.

Event Description

Information was received based on review of a journal article titled, " failure of a unipolar radial head prosthesis" which aimed to orthopedic surgeons the many options when considering radial head replacement implants and should be aware of the potential complications of each.The authors present this case to show one potential complication of unipolar prosthetic radial head implant arthroplasty.A patient was identified in the article that underwent an elbow arthroplasty on an unknown date.Subsequently, patient underwent a revision procedure due to pain, catching, dissociation of the radial head from the stem and the set screw backing out, and resorption of the proximal radius from stress shielding.During the revision procedure, the surgeon noted extensive metallosis and significant erosion of capitellum cartilage.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.Date of event - unknown date, 2013.Explant date - unknown date, 2013.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions.Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts.The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process.Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid.It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." there are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "properly align and properly seat connecting components, including tapers.Failure to properly align and completely seat the components together can lead to disassociation.Thoroughly clean and dry all connectors, including tapers prior to attachment of modular components to avoid crevice corrosion and improper seating.".

Event Description

Information was received based on review of a journal article titled, "failure of a unipolar radial head prosthesis" which aimed to orthopedic surgeons the many options when considering radial head replacement implants and should be aware of the potential complications of each.The authors present this case to show one potential complication of unipolar prosthetic radial head implant arthroplasty.A patient was identified in the article that underwent an elbow arthroplasty with a subsequent revision approximately 5 years post-implantation due to pain, catching, dissociation of the radial head from the stem and the set screw backing out, and resorption of the proximal radius from stress shielding.During the revision procedure, the surgeon noted extensive metallosis and significant erosion of capitellum cartilage.All products were removed and no products were implanted.One year post-implant removal, the patient was doing well with only occasional mild discomfort.

• Brand Name: EXPLOR 16X22MM IMPLANT HEAD
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5908835
• MDR Text Key: 53285119
• Report Number: 0001825034-2016-03353
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-210034
• Device Lot Number: 027360
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR